Ex Parte Hansen et al

Patent Trial and Appeal Board

Feb 27, 2017

13551830 (P.T.A.B. Feb. 27, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/551,830 07/18/2012 Timothy R. Hansen BECTON 3.0-053 CON
CON CO
9074
63863 7590 03/01/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Lerner David Littenberg)
1 Becton Drive , MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
BOWERS, NATHAN ANDREW
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
03/01/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
lorraine_kow alchuk @ bd .com
ip_docket @bd.com
eOfficeAction @ ldlkm. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY R. HANSEN, MATTHEW P. COLLIS,
BRADLEY S. THOMAS, and THOMAS L. FORT
Appeal 2016-000382
Application 13/551,8301
Technology Center 1700
Before JEFFREY T. SMITH, DONNA M. PRAISS, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision2 finally rejecting claims 16—22, 24—26, and 28—31 in the above-
identified application. We have jurisdiction pursuant to 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify Becton, Dickinson and Company as the real party in
interest. Appeal Br. 1, April 23, 2015.
2 Office Action, Sept. 5, 2014 [hereinafter Action]; Examiner’s Answer, Aug.
4, 2015 [hereinafter Answer],
Appeal 2016-000382
Application 13/551,830
BACKGROUND
Appellants’ invention “is related to a system and method for the
isolation, amplification and detection of targeted nucleic acids in a fully
automated and integrated system that comprises a pipetter, extractor and an
assay reader, as well as many other devices, to detect the targeted nucleic
acids.” Spec. 12. Claim 16 recites a representative embodiment, as
follows:
16. A method for processing a component of interest
contained in a sample, comprising:
receiving at least one tube containing a sample in a
sample rack;
automatically transferring the sample from the tube to an
extraction device comprising a tube using a selectively
compliant articulated robot arm (SCARA);
operating the extraction device to extract said component
of interest from the sample while the sample is disposed in the
extraction device tube;
automatically transferring the extracted component of
interest from the extraction tube in the extraction device to a
primer well and from a primer well to an amplification/reader
well-disposed in an amplification plate, wherein the
automatically transferring includes operating the SCARA to
perform said transferring;
automatically picking up a plate seal gripper tool and
sealing the amplification plate using the SCARA;
moving the amplification plate to a detector wherein the
amplification plate is moved using the SCARA; and
operating a detector to detect for the presence of said
component of interest extracted by said extraction device.
Appeal Br. 16.
Method claims 26, 28, and 31 are also independent, and include
similar steps to the “operating” and “automatically transferring” steps
emphasized above in claim 16. Claim 26 recites these steps as “extracting
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Appeal 2016-000382
Application 13/551,830
the nucleic acid from the sample with an extractor” and “transferring the
extracted nucleic acid from the extractor tube.” Id. at 18. Claim 28 requires
steps of “operating an extractor comprising a tube ... to extract the nucleic
acid from the sample” and “automatically transferring the extracted nucleic
acid from the extractor tube.” Id. Claim 31 requires steps of “automatically
separating the target sequence from the fluid sample at a separation station”
and “automatically transporting the separated target sequence from the
separation station.” Id. at 19.
The Examiner maintains the following grounds of rejection:
I. Claims 16—19 and 24—26 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Reichler3 in view of Andrews,4 DeWitt,5 and
Earley.6 See Action 3—7.
II. Claims 20—22 and 28—31 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Reichler in view of Andrews, DeWitt, and Earley,
and further in view of Reeve.7 See Action 7—8.
DISCUSSION
In rejecting independent claims 16 and 26, the Examiner finds that
Reichler teaches a method of processing a sample in which samples
“undergo decontamination (extraction) in order to remove various
3 Reichler et al., U.S. Patent No. 5,578,270 (issued Nov. 26, 1996).
4 Andrews et al., U.S. Patent No. 6,043,880 (issued Mar. 28, 2000).
5 DeWitt et al., U.S. Patent No. 5,714,127 (issued Feb. 3, 1998).
6 Earley et al., U.S. Patent No. 5,455,008 (issued Oct. 3, 1995).
7 Reeve, Inf 1 Patent Application No. WO 91/12079 (published Aug. 22,
1991).
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Appeal 2016-000382
Application 13/551,830
impurities, and then are subject to amplification via a thermal cycling
operation.” Action 3.
Reichler is directed to solving a cross-contamination problem that can
occur as a result of using separate containers to perform decontamination
and amplification steps. See Reichler 1:46—2:44. Figure 12 of Reichler is
reproduced below:
Figure 12 depicts a cross-sectional view of reaction device 88, which the
Examiner identifies as the “extraction device” or “extractor” of claims 16
and 26. See Action 3. The reaction device 88 is depicted as a horizontal
tube. On the left is sample tower 262 into which a sample is introduced
through sample port 304. At the opposite end of the tube on the right is
pneumatic tower 266 that includes pneumatic port 310 from which air is
withdrawn to move a bolus of the sample down the tube. The tube contains
decontamination zone 312 where the sample contacts dried decontamination
reagents 316, after which the sample bolus moves to amplification zone 318,
304
\
268
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Appeal 2016-000382
Application 13/551,830
where it makes contact with dried amplification reagents 320. See Reichler
16:26-63.
The Examiner acknowledges that in Reichler, the extraction and
amplification operations “are performed in the same well container,” and
therefore Reichler “does not expressly indicate that separate extraction
tubes, primer wells and amplification plates are utilized to perform discrete,
stepwise operations.” Action 3^4. However, the Examiner cites Andrews as
teaching that extraction, amplification, and other steps may be performed in
separate containers. See id. at 4. Comparing claim 16 to the Andrews
disclosure, the Examiner associates the step of “extraction” with the thermal
lysing reaction that takes place in tubes 108 of Andrews. Action 4; see also
Answer 3. A biological sample is placed in tubes 108, after which the tubes
are heated until the cells in the sample burst to release their DNA. Andrews
6:47—56. Afterwards, a technician uses pipette tips to withdraw “some of the
fluid sample” from tubes 108 and move them to a primer well assembly. See
id. at 6:57—65. Thus, the Examiner concludes that
it would have been obvious to perform an alternative extraction,
amplification and detection operation when using the automated
system of Reichler. As evidenced by Andrews, the use of distinct
extraction tubes, primer wells and amplification plates when pre­
paring a nucleic acid sample is well known in the art. One of
ordinary skill would have found it beneficial to automate the
method of Andrews using the robotic pipetting assembly de­
scribed by Reichler.
Id.
The Examiner’s rejection of independent claims 28 and 31 relies on
the same rationale as above, which includes the combination of Reichler and
Andrews to teach the extraction and removal of a nucleic acid from a
sample. See Action 8.
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Application 13/551,830
Appellants argue that Reichler only teaches a reaction device in which
decontamination and amplification reactions occur, and not an “extraction
device” as required by claim 16. See Appeal Br. 5. Appellants also argue
that Reichler teaches that these two reactions occur in a closed system, in
which the reaction device itself is transferred by the robotic system, and does
not teach the extraction of a component of interest from the device itself, and
transferring the component of interest from the extraction tube to other
containers, as required by the claims. See Appeal Br. 6, 8—9; Reply Br. 6.
We begin our analysis by interpreting the scope of claims 16, 26, 28,
and 31, giving the claims their broadest reasonable interpretation in light of
the Specification. See In re Man Machine Interface Techs. LLC, 822 F.3d
1282, 1287 (Fed. Cir. 2016). Each of these claims requires that a component
of interest (specifically, a nucleic acid in claims 26, 28, and 31) is
automatically extracted or separated “from” the sample. See Appeal Br. 16,
18—19. Based on the plain meaning of the claims, this requires isolating and
separating the component of interest from the remaining components in the
sample. This is consistent with the Specification, which frames the claimed
invention as a solution to the problem of automating the separation of
nucleic acids from the remaining cell components in a sample. See Spec.
114—6. The Specification also states that the purpose of an extractor is “to
isolate and concentrate nucleic acid from [an] input sample,” id. 1 60, and
that it is used for “isolating the component of interest,” id. 151.
To establish obviousness of a claimed invention, all the claim
limitations must be taught or suggested by the prior art. See In re Royka,
490 F.2d 981, 985 (CCPA 1974). In light of our claim interpretation, the
Examiner’s findings do not support the rejection of claims 16, 26, 28, and 31
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Application 13/551,830
as obvious over Reichler, Andrews, DeWitt, and Early because the Examiner
has not persuasively shown that the combination discloses isolating and
separating a component of interest (a nucleic acid, in the case of claims 26,
28, and 31) from the remaining components in a sample. In Reichler, a
“decontamination” reaction occurs in reaction device 88, but it is not
apparent from the Examiner’s findings that this reaction constitutes an
isolation or separation of a component of interest from other components in
the sample. The secondary references cited by the Examiner do not cure this
deficiency. In Andrews, for example, thermal lysing occurs in tubes 108,
which releases nucleic acids from cells. However, the Examiner has not
shown that the lysing step in tubes 108 also includes the isolation and
separation of the nucleic acids from the remaining cell components.
For the above reasons, the Examiner reversibly erred in rejecting
independent claims 16, 26, 28, and 31. Because the Examiner’s rejection of
the dependent claims also relies on this error, we reverse the Examiner’s
decision to reject claims 16—22, 24—26, and 28—31.
DECISION
The Examiner’s rejections are reversed.
REVERSED
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